Getting the Deal Through: Pharma & Medical Device Regulation 2021
Getting the Deal Through: Pharma & Medical Device Regulation 2021

The following In-house Advisor practice note provides comprehensive and up to date legal information covering:

  • Getting the Deal Through: Pharma & Medical Device Regulation 2021
  • Jurisdictions covered
  • Questions

Jurisdictions covered

The following jurisdictions are covered in this report:

Australia; Austria; Brazil; China; Colombia; Denmark; European Union; France; Germany; India; Italy; Japan; Mexico; New Zealand; Serbia; South Korea; Sweden; Switzerland; Turkey; United Kingdom; USA

Questions

The set of questions relating to the topic of Pharma & Medical Device Regulation and answered by the guide for each jurisdiction covered include:

  1. Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

  2. Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?

  3. Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.

  4. What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?

  5. What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?

  6. Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?

  7. How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

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